What side effects are associated with this type of intervention?

Common treatments for liver cirrhosis include medications to manage symptoms and complications, such as diuretics, beta-blockers, and lactulose. Treatments similar to the green tea catechin extract, which aim to prevent liver cancer by lowering oxidative stress and inflammation, include antioxidants like vitamin E and herbal supplements. Known side effects of these treatments can include gastrointestinal issues (nausea, diarrhea), fatigue, and, in some cases, more serious effects like liver toxicity or interactions with other medications. It is important to consult with a healthcare provider to tailor treatment to individual needs and monitor for adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for liver cirrhosis primarily focus on managing symptoms and complications rather than directly preventing liver cancer. Commonly approved drugs include ursodeoxycholic acid (ursodiol) for primary biliary cirrhosis, which helps improve liver function and reduce bile acid levels. Other treatments involve managing complications such as portal hypertension, ascites, and hepatic encephalopathy. While green tea catechin extract is being studied for its potential to lower gamma-OHPdG levels and prevent liver cancer, there are no FDA-approved treatments specifically targeting this pathway in cirrhosis patients.

What other types of research exist?

Promising alternatives to Defined Green Tea Catechin Extract for liver cirrhosis patients include Epigallocatechin-gallate (EGCG), which has shown hepatoprotective and chemopreventive effects against hepatocellular carcinoma, and Sho-saiko-to (TJ-9), which has been studied for chemoprevention of hepatocellular carcinoma. Both compounds have demonstrated potential in reducing liver damage and preventing liver cancer.

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Cancer Preventive Agent

Green Tea Extract for Liver Cirrhosis

Q: What is the mechanism of action of this treatment?

Green tea catechins, especially epigallocatechin-3-gallate (EGCG), are known for their hepatoprotective effects. They reduce oxidative stress and inflammation in the liver, which are critical in the progression of liver cirrhosis. By lowering levels of harmful molecules like gamma-OHPdG, which are linked to a higher risk of liver cancer, green tea catechins may help prevent the development of liver cancer in cirrhosis patients. This is significant as it can improve the prognosis and quality of life for these patients.

Phase 1

Waitlist Available

Led By Aiwu R He

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

Absence of ascites and encephalopathy

Must not have

Known mental incapacitation affecting ability to consent

Inability to swallow capsules

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to and at 1.5, 3.5, and 8.5 hours after the first dose of polyphenon e on day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of a green tea extract on people with cirrhosis. The goal is to find the best dose and see if it can lower a molecule linked to liver cancer. By reducing this molecule, the treatment may help prevent liver cancer in these patients. Green tea extract has been shown to protect against various forms of liver damage, including those induced by alcohol, acetaminophen, and carbon tetrachloride.

Who is the study for?

Adults diagnosed with cirrhosis who can undergo imaging tests like ultrasound, CT, or MRI. They must have a good performance status (able to carry out daily activities), adequate blood counts and liver function, no history of certain cancers within the last 3 years except some localized ones, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with bleeding risks, allergies to green tea components, recent consumption of green tea products, other active cancers requiring systemic treatment or hepatic decompensation events.

What is being tested?

The trial is testing defined green tea catechin extract's ability to prevent liver cancer in cirrhotic patients by lowering gamma-OHPdG levels. Participants will receive varying doses of this extract while being monitored through imaging studies and laboratory biomarker analysis for any changes in their condition.

What are the potential side effects?

While traditional green tea consumption is generally safe over thousands of years of use, high doses as used in this study may present unknown risks. Possible side effects could include gastrointestinal issues due to the nature of the compound but specific side effects related to high-dose Polyphenon E are not well-known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I do not have fluid buildup in my abdomen or brain function issues.

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My kidney function is normal.

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I am 18 years old or older.

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I have been diagnosed with cirrhosis through a biopsy, imaging, or a special liver test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am mentally capable of understanding and consenting to treatment.

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I cannot swallow pills.

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I haven't had any cancer except for certain types in the past 3 years.

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I have had liver failure events in the past.

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I do not have any uncontrolled illnesses.

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I am prone to bleeding in my stomach or rectum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to and at 1.5, 3.5, and 8.5 hours after the first dose of polyphenon e on day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to and at 1.5, 3.5, and 8.5 hours after the first dose of polyphenon e on day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and at 1.5, 3.5, and 8.5 hours after the first dose of polyphenon e on day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in gamma-hydroxy-1,N(2)-propanodeoxyguanosine (gamma-OHPdG) expression in cirrhotic liver

Maximum tolerated dose of Polyphenon E

Secondary study objectives

Change in gamma-OHPdG

Fraction of patients with liver cirrhosis that have high levels of gamma-OHPdG

Polyphenon E pharmacokinetic data in blood and urine in patients with cirrhosis

Other study objectives

Grade of cirrhosis

Incidence of hepatocellular carcinoma

Liquid chromatography-mass spectrometry (LC-MS) and/or enzyme-linked immunosorbent assay (ELISA)-based method for detecting gamma-OHPdG

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (defined green tea catechin extract)Experimental Treatment9 Interventions

Participants receive defined green tea catechin extract PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound, CT, or MRI at screening and on study, undergo collection of blood samples on study, and may undergo biopsy at screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

Biopsy

2014

Completed Phase 4

~1150

Defined Green Tea Catechin Extract

2008

Completed Phase 2

~40

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Ultrasound

2013

Completed Phase 1

~4090

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Green tea catechins, especially epigallocatechin-3-gallate (EGCG), are known for their hepatoprotective effects. They reduce oxidative stress and inflammation in the liver, which are critical in the progression of liver cirrhosis. By lowering levels of harmful molecules like gamma-OHPdG, which are linked to a higher risk of liver cancer, green tea catechins may help prevent the development of liver cancer in cirrhosis patients. This is significant as it can improve the prognosis and quality of life for these patients.